Elevate your career at Puzzle Medical Devices® Inc. as a Quality Specialist in Montreal. This full-time, in-person role focuses on ensuring high standards in medical device manufacturing and validation.
In this critical position, you will support the development and compliance of a percutaneous heart pump system. As a Quality Specialist, your responsibilities include managing supplier quality, guiding compliance with ISO 13485 standards, and participating in regulatory inspections. You will actively engage with cross-functional teams to maintain high-quality production standards.
Key Responsibilities:
- Qualify and manage suppliers per regulatory standards
- Review supplier documentation and certifications
- Support quality investigations and nonconformance resolutions
- Execute software validation activities and maintain documentation
- Collaborate with R&D, manufacturing, and regulatory teams
Requirements:
- Bachelor's degree in Mechanical, Biomedical, or related field
- Experience in a regulated medical device environment
- Knowledge of ISO 13485 and FDA QMSR
- Strong analytical mindset and organizational skills
- Excellent communication in cross-functional settings
Bring your quality assurance expertise to help shape innovative medical solutions with Puzzle Medical Devices® Inc.
Full-Time Quality Specialist in Montreal in Montréal employer: Puzzle Medical Devices® Inc.
At Puzzle Medical, we pride ourselves on being an exceptional employer dedicated to advancing patient care through innovative technology. Our collaborative MedTech environment fosters initiative and values your ideas, providing ample opportunities for professional growth and meaningful contributions. With a comprehensive benefits package, including generous vacation time, wellness support, and a vibrant team culture, you’ll find a rewarding workplace that prioritizes both your career and well-being.
Contact Details:
Puzzle Medical Devices® Inc. Recruitment Team
